Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT05033795
Eligibility Criteria:
Inclusion Criteria:
* healthy female subjects
* in good health without disease with an ICD code in compliance with the World Health Organisation definition (a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." )
* abstemious
* individuals who agree to sign an informed consent form
* individuals who follow an omnivorous diet
Exclusion Criteria:
* subjects outside the age range considered
* smokers and/or those with chronic or acute diseases coded by the ICD-10 system
* persons who do not consent to sign the informed consent form
* subjects who follow diets that are not omnivorous or with fattening / slimming purposes
* subjects undergoing hormonal or contraceptive hormonal therapies or in general drugs that may alter the hydroelectric balance
* persons with significant alterations in the menstrual cycle (amenorrhoea or dysmenorrhoea).
* use of alcohol.
* pregnancy (verified by self-declaration) and/or breastfeeding
* allergy to the components of Leukopor
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT05033795
Study Brief:
Protocol Section:
NCT05033795